Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study

Hip Fractures Clinical Trial

Official title:

Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984385
• Other study ID #: HipVISION Pilot - 2013
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: October 5, 2015
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This pilot study will assess the feasibility of a larger prospective international cohort study. After eligibility has been confirmed and informed consent has been obtained, participants will be registered in the study. Troponin level, complete blood counts and serum creatinine level will be collected at day 1 through day 10 post admission. CAM instrument will be employed at admission and once daily post admission day 1 through day 10. FIM Instrument will be administered within 72 hours of admission to establish pre-fracture functional independence and disability. Patients will be contacted by research personnel by telephone 30 days after study registration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged = 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively

2. Mechanism of injury consistent with either:

1. A fall from a standing height or;

2. Another mechanism of injury which, in the clinical judgment of an orthopedic surgeon, would impart the same or less traumatic energy as a fall from a standing height

Exclusion Criteria:

1. Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region

2. Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height

3. Patient who refuse 30-day or 6-month follow up

4. Patients who refuse to consent either by themselves or through a substitute decision-maker (for patients unable to consent, we will use a deferred consent process, as described below).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Locations

Country	Name	City	State
Canada	Juravinski Hospital and Cancer Centre (HHS)	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and cause specific mortality in hip fracture patients at 30 days		30 days	No
Primary	Major complications within 30 days.	Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.	30 days	No
Secondary	Nonfatal myocardial infarction		30 days	No
Secondary	Nonfatal myocardial injury after noncardiac surgery		30 days	No
Secondary	Nonfatal pulmonary embolism		30 days	No
Secondary	Nonfatal infection		30 days	No
Secondary	Nonfatal bleeding		30 days	No
Secondary	Nonfatal stroke		30 days	No
Secondary	New congestive heart failure		30 days	No
Secondary	New atrial fibrillation		30 days	No
Secondary	Nonfatal cardiac arrest		30 days	No
Secondary	Deep vein thrombosis		30 days	No
Secondary	New acute renal failure requiring dialysis		30 days	No
Secondary	Cardiac catheterization		30 days	No
Secondary	PCI		30 days	No
Secondary	CABG		30 days	No
Secondary	CAM days 1-7 post-op		1-7 days post-op	No
Secondary	Implant failure or periprosthetic fracture		30 days	No
Secondary	Re-operation		30 days	No
Secondary	Length of hospital stay		30 days	No
Secondary	New nursing home residence		30 days	No
Secondary	First mobilization		30 days	No
Secondary	FIM (motor function)		30 days	No